Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
CAMZYOS 2.5 mg hard capsules.
CAMZYOS 5 mg hard capsules.
CAMZYOS 10 mg hard capsules.
CAMZYOS 15 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). CAMZYOS 2.5 mg hard capsules: Light purple opaque cap imprinted with “2.5 mg” in black, and white opaque body imprinted with “Mava” in black, both in radial direction. Capsule size of approximately 18.0 mm in length. CAMZYOS 5 mg hard capsules: Yellow opaque cap imprinted with “5 mg” in black, and white opaque body imprinted with “Mava” in black, both in radial direction. Capsule size of approximately 18.0 mm in length. CAMZYOS 10 mg hard capsules: Pink opaque cap imprinted with “10 mg” in black, and white opaque body imprinted with “Mava” in black, both in radial direction. Capsule size of approximately 18.0 mm in length. CAMZYOS 15 mg hard capsules: Grey opaque cap imprinted with “15 mg” in black, and white opaque body imprinted with “Mava” in black, both in radial direction. Capsule size of approximately 18.0 mm in length. |
CAMZYOS 2.5 mg hard capsules: Each hard capsule contains 2.5 mg of mavacamten.
CAMZYOS 5 mg hard capsules: Each hard capsule contains 5 mg of mavacamten.
CAMZYOS 10 mg hard capsules: Each hard capsule contains 10 mg of mavacamten.
CAMZYOS 15 mg hard capsules: Each hard capsule contains 15 mg of mavacamten.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mavacamten |
Mavacamten is a selective, allosteric, and reversible cardiac myosin inhibitor. Mavacamten modulates the number of myosin heads that can enter power-generating states, thus reducing (or in HCM normalizing) the probability of force-producing systolic and residual diastolic cross-bridge formation. Mavacamten also shifts the overall myosin population towards an energy-sparing, but recruitable, super-relaxed state. In HCM patients, cardiac myosin inhibition with mavacamten normalises contractility, reduces dynamic LVOT obstruction, and improves cardiac filling pressures. |
| List of Excipients |
|---|
|
Capsule content: Silica, colloidal hydrated Capsule shell: All strengths: Gelatin CAMZYOS 2.5 mg hard capsules: Iron oxide black (E172) CAMZYOS 5 mg hard capsules: Iron oxide yellow (E172) CAMZYOS 10 mg hard capsules: Iron oxide red (E172) Printing ink: Iron oxide black (E172) |
Polyvinylchloride (PVC) / Polychlorotrifluoroethylene (PCTFE) / Aluminium foil blister containing 14 hard capsules.
Pack size of 14 or 28 hard capsules.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/23/1716/001-008
| Drug | Countries | |
|---|---|---|
| CAMZYOS | Austria, Canada, Cyprus, Estonia, Finland, France, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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